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Ciprofloxacin Versus Ceftazidime as Empirical Therapy of High-Risk Neutropenic Fever in Children With Hematologic Malignancies : A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

This clinical trial will compare use of ciprofloxacin and ceftazidime work in treating high-risk fever in children with hematological malignancies 1. Does ceftazidime work better than ciprofloxacin as a first-choice antibiotic for children with hematological malignancies who have high-risk fever from low neutrophil count? 2. Are there any specific factors that affect how children with hematological malignancies respond to ciprofloxacin or ceftazidime when treating high-risk fever? Participants in this study are children with hematological malignancies who have a high risk of fever due to low neutrophil count. Children, aged 0 to 18 years old, will be hospitalized between June and December 2025 at Sardjito General Hospital The study will involve: * Collecting patient history, conducting physical exams, and performing supporting tests. * Randomly assigning participants into two groups: one group will receive the standard treatment with intravenous ciprofloxacin, while the other group will receive the intervention treatment with intravenous ceftazidime. * Both groups will be monitored for various outcomes, including the length of fever, length of low white blood cell count, length of hospital stay, length of antibiotic use, any changes in antibiotics, and mortality.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 18
Healthy Volunteers: f
View:

• Children aged 0 to 18 years with hematological malignancies.

• Children with high-risk neutropenic fever, namely children with blood malignancies induction phase ALL, consolidation phase ALL, reinduction phase ALL, relapse ALL; meningeal ALL, AML, and NHL, diagnosed by a competent pediatrician on duty.

• Consent from parents to be included in the study.

Locations
Other Locations
Indonesia
RSUP dr Sardjito
RECRUITING
Sleman
Contact Information
Primary
dr. Khairunisa Rahma Handayani, Medical doctor
khairunisarahma99@mail.ugm.ac.id
+6281246572652
Time Frame
Start Date: 2025-06-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 120
Treatments
Active_comparator: Group A
Standard therapy IV ciprofloxacin 10 mg/kgBW/12 hours
Experimental: Group B
IV ceftazidime 150 mg/kgBW/24 hours divided into 3 doses
Sponsors
Leads: Gadjah Mada University

This content was sourced from clinicaltrials.gov